Congenital Heart Diseases Clinical Trial
Official title:
A Randomized, Controlled Trial Evaluating Efficacy of Perioperative Organ Protection as Well as Safety of Ulinastatin Use in Pediatric Patients Undergoing Open Heart Surgery Through CPB to Treat Complex Congenital Heart Diseases
1. Explore the efficacy of Ulinastatin use in improving post-operative pulmonary
insufficiency and safety in pediatric patients undergoing scheduled CPB open heart
surgery to treat Complex Congenital Heart Disease
2. Explore the efficacy of Ulinastatin use in improving intraoperative hemodynamic
instability as well as other post-operative organ recuperation and its impact on
hospital stay & cost
Pediatric patients diagnosed with Complex Congenital Heart Disease ready to accept scheduled
open-heart surgery under cardiopulmonary bypass (CPB).
This study uses randomized (centralized randomization) & controlled design with open label.
Eligible subjects will be randomized to receive either study drug (Ulinastatin) or
conventional treatment.
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